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How NAVA Works in Preterm Infants With Irregular Respiratory Efforts

How NAVA Works in Preterm Infants With Irregular Respiratory Efforts

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04659083
Enrollment
18
Registered
2020-12-09
Start date
2020-03-01
Completion date
2020-12-31
Last updated
2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation, Neurally Adjusted Ventilatory Assist, Premature Infants, Ventilator Lung; Newborn

Brief summary

For the infant participating the study, ventilator settings and respiratory variables will be recorded every day and exported to a specific computer using the Servo Record Viewer version 1.0 (Maquet Critical Care AB, Getinge, Gothenburg, Sweden). Collected data gives the value for peak inspiratory pressure (PIP), expiratory tidal volume (Vt), peak Edi, minimum Edi, measured respiratory rate (RR), neural respiratory rate (nRR) and percentage of backup breaths for each minute. All the ventilator data will be inspected and compared with the event logs recorded automatically from the ventilator, which includes all the alarm notification, mode and setting changes, cables connection and disconnection data. Data during disconnection of the Edi cable, malfunction or dislocation of Edi catheter will be excluded from the analysis. The mean values during each day will be computed for each ventilatory variables. If there is a change in the ventilatory setting parameters, we will choose the one which was applied for longer duration in the 24-hour time period. The following clinical characteristics will be collected from medical records: gestational age at birth, birth weight, gender, the time and amount of feeding, medication during the study days, desaturation events, bradycardia events, suction time and methods.

Interventions

DEVICENeurally adjusted ventilatory assist ventilation mode

This technique uses the electrical activity of the diaphragm (Edi) to control respiratory support and the NAVA level as an amplification factor that converts the Edi signal into a proportional pressure.

Sponsors

Turku University Hospital
CollaboratorOTHER_GOV
Inha University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 36 Weeks
Healthy volunteers
Yes

Inclusion criteria

* babies who receiving respiratory support with neurally adjusted ventilatory assist * babies with informed consents from their parents

Exclusion criteria

* babies using anesthetic agents

Design outcomes

Primary

MeasureTime frameDescription
the amount of backup breaths by the ventilatorduring the respiratory support using NAVA, from day 1 until the end of 36 weeks of postmenstrual age% time of backup/min according to babies' weight, postmenstrual age and postnatal age

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026